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NCT04996758
Toripalimab and Anlotinib Combination Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of at Least One Line of Platinum-Based Chemotherapy (TORAL)
Phase 2 trial testing Toripalimab and Anlotinib in Nasopharyngeal Carcinoma in 40 participants. Completed in 1 December 2024.
30 September 2023
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 30 October 2021 |
| Primary completion | 30 September 2023 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Toripalimab and Anlotinib — full drug profile →
Conditions studied
- Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
- Recurrent or Metastatic Nasopharyngeal Carcinoma — all drugs for Recurrent or Metastatic Nasopharyngeal Carcinoma →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Nasopharyngeal Carcinoma or Recurrent or Metastatic Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase 2 trial studies toripalimab and anlotinib combination treatment in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least one line of platinum-based chemotherapy
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recurrent/Metastatic Nasopharyngeal Carcinoma Treatment from Present to Future: Where Are We and Where Are We Heading?
Juarez-Vignon Whaley JJ, Afkhami M, Onyshchenko M, Massarelli E, et al · · 2023 · cited 71× · PMID 37318724 · DOI 10.1007/s11864-023-01101-3 -
Toripalimab plus anlotinib in patients with recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm phase 2 trial (TORAL).
Zhang Y, Zou Q, Zhao B, Su N, et al · · 2024 · cited 11× · PMID 39615484 · DOI 10.1016/j.xcrm.2024.101833 -
Anlotinib as a third-line or further treatment for recurrent or metastatic nasopharyngeal carcinoma: a single-arm, phase 2 clinical trial.
Fang Y, Su N, Zou Q, Cao Y, et al · · 2023 · cited 8× · PMID 37936166 · DOI 10.1186/s12916-023-03140-x -
Anlotinib reversed resistance to PD-1 inhibitors in recurrent and metastatic head and neck cancers: a real-world retrospective study.
Jiang J, Wu B, Sun Y, Xiang J, et al · · 2024 · cited 4× · PMID 39105897 · DOI 10.1007/s00262-024-03784-5 -
The efficacy and safety of EGFR-TKI in recurrent/metastatic nasopharyngeal carcinoma patients: A systematic review and meta-analysis.
An Z, He L, Chen T, Liang B, et al · · 2024 · cited 1× · PMID 38803463 · DOI 10.1002/lio2.1279
Verify or expand the search:
- PubMed search for NCT04996758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Toripalimab and Anlotinib
Trials testing the same drug.
- NCT05087602 — Toripalimab Combined With Anlotinib in Unresectable Locally Advanced or Metastatic Acral Malignant Melanoma · Phase 2 · unknown
Other recruiting trials for Nasopharyngeal Carcinoma
Currently open trials in the same condition.
- NCT06059261 — Envafolimab Combined With Chemoradiotherapy and Recombinant Human Endostatin for LA-NPC. · Phase 2 · recruiting
- NCT07328854 — 40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma · Phase 3 · recruiting
- NCT06912711 — TN Induction and Adjuvant Therapy for Resectable Local Recurrent Nasopharyngeal Carcinoma · Phase 2 · recruiting
- NCT07000643 — Phase III Non-Inferiority Trial of Proton Versus Photon Therapy for Nasopharyngeal Carcinoma · Phase 3 · recruiting
- NCT06682442 — Induction Chemotherapy Response-Guided Radiation for EBV-Associated Nasopharyngeal Carcinoma · NA · recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04996758 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 12 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04996758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing